information management in pharmaceutical industry

INFORMATION MANAGEMENT IN

BIOPHARMA INDUSTRIES

CHALLENGES AND OPPORTUNITIES

Frank Wang

• Challenges of Pharmaceutical R&D and Clinical, Sales and Marketing Productivity

• Evolving Biopharma Value Chain

• Information Management in Pharmaceutical R&D and Clinical Value Chain

• Information Management in Pharmaceutical S&M and Managed Care

• Information Management in Manufacturing and Distribution (Supply Chain Optimization)

• Information Management to help IT Organization to run like a Business

TOPICS

PHARMACEUTICAL INDUSTRY IS AT A CROSS-ROAD. WHILE R&D PRODUCTIVITY SAGS,

EMERGING MARKETS, RECESSIONS, HEALTHCARE REFORMS AND DEMOGRAPHICS

ARE FUNDAMENTALLY CHANGING THE LANDSCAPE.

• Rising demographic pressures as populations age. Mature

countries large impact in 3-5 years, BRIC countries in 15-25

years.

• Large scale entry of developing nations with adequate

infrastructure leading to new market share opportunities

(>50% of growth from emerging markets).

• Research productivity dropped significantly while R&D

expenses dramatically increased. Fewer blockbusters, more

extensions; patent cliffs with generics; precision medicine.

• The rise of biologics and genome-based therapies seen as

new source of innovation but genome based research has

not yet fulfilled its promise.

• Conflict of interest and fear of corporate influence driving

new regulations affecting corporate-physician relationships.

• Recession and Healthcare Reform mandate require clear

value prepositions of new molecular entities, new

commercial business models and increased supply chain

agility.

• R&D

― Focus on precision medicine to find segmented populations for

line extensions, off-label and new specialty drug uses; the rise of

disease management programs

― Large scale pipeline renewal (process, organization, technology

and therapeutic area focus) through R&D reorgs and M&A to

refresh future funding sources. Shift R&D to developing nations

and outsource to reduce costs and efficiencies

• Manufacturing and Supply Chain

― Reduce manufacturing footprint; outsource more manufacturing

― Revitalize supply chain by adopting best of the breed

manufacturing supply chain excellence such as lean

manufacturing, demand forecasting and inventory optimization

• Sales and Marketing

― Differentiated sales and marketing strategies (segmentation)

required to reach emerging markets, mature vs. novel products

and therapeutic-specific patients; tailored communications by

segment by channel

― Socialized medicine cost pressures increase regulation in EMEA

and developed countries; price controls drives unified approach

to legal/safety, R&D and S&M

― Reduced access to Primary care as well as Specialty Physicians

and Managed care in US markets requires new S&M

approaches

Market and Industry Forces Impact

1

3

5 6

4

HP’S VIEW OF FUTURE OF PHARMA VALUE CHAIN IN CORE

MARKETS

Discovery shifting away from blockbuster

• Targeted treatment based on biomarker & Px

• Focus on cure and prevention (convergence of Rx, Dx and devices)

• Research Collaboration and offshoring: High % of Research executed through biotech and academia; high % of research executed in emerging markets

• EHR data mining, convergence of informatics of providers, payers and biopharma

Development paradigm shifting to in-life monitoring

• New clinical model, from adaptive trial to enrichment strategies to screen and select patients for targeted therapy will result in reduced costs and time needed for Phase III trial

• Development Collaboration and offshoring: High % of development executed by CROs, and more development conducted in emerging markets

• Closer coupling with Providers, Payers, Government, Regulators to share clinical infrastructure

• Collaboration between Regulatory Bodies and Industry on an expedited drug development pathway

4

2

Technical Operation modernizing

• Increased complexity due to precision medicine, combination therapy, new delivery technologies

• Personalized dosage, lean principles, supply chain analytics

• New production sites and outsourcing to CMOs and offshoring in emerging markets

• Continued emphasis on cGMP

Sales transforming in core markets

• Sales model changes from product driven to disease-management driven

• Bundled selling model emerge which may include Rx, Dx, Devices and supportive packages such as compliance monitoring and home delivery

• Smaller but more specialized sales force; different sales model for mature and new products

• Provides advisory, training and service roles

Marketing transforming in core markets

• Evidence-based medicine marketing, pay for performance pricing and reimbursement demanded by Managed Market

• Investment focus on initial product launch and post marketing surveillance

• Post launch marketing shifts from physician-centric to patient-centric

• Collaboration with Providers, Payers and Government to improve patient outcomes

Distribution partnering in core markets

• E-pedigree

• Direct to pharmacy and newer channels

• Patient-outcome based payment changes financial model

• Collaboration with whole sales, specialty distributors, PBM and pharmacies to increase patient adherence

PHARMA R&D AND CLINICAL

• Business Processes

• Paradigm Shift

• Information Management Challenges and Maturity Model

• Information Management Opportunities

Target ID

Validation Lead Identification

(Assay Dev/Screening)

Lead

Optimization

Preclinical Animal

Testing

Clinical

Support

Information Management and Knowledge Sharing along the Pharmaceutical R&D Value Chain

Genomics Proteomics Bioinformatics Images Pathways Systems Biology

Compound Registration Compound Inventory Screening Databases Project Mart Computational Chemistry Cheminformaitcs (e-ADME) Rational Drug Design

Biology Therapeutic Centric DW Corp R&D Knowledge Managment Corp Compound Management

IND Submission GLP/GMP Validation Part 11 CRF 21 Content Management Documentum

Stability Scale-up TotalChrom LIMS Process Control CMC Strategies

Project Portfolio Managment Collaboration, Portal, IP Management, CTI

Data Governance, Data Integration, Information Management and Knowledge Sharing

Tox LIMS Bioanalytics LIMS Animal Pharmacology PK/PD Toxicogenomics Metabonomics

Non Clinical

Development

Clinical Trial Supply Clinical PK Manufacturing R&D

Phase I Phase II Phase III Regulatory

NDA Submission Phase IV

Information Management Along the Pharmaceutical Clinical Operation, Regulatory Affairs and Post-marketing Surveillance

Web-based EDC in traditional phases and adaptive trials Design and Plan Start-up (Distribute Drug info, Site Selection) Recruiting Patients/Investigators Trial Management and Monitoring Conduct, Reports and Closeout

CTDM CTMS Clinical Data Repository (SCE, eCDM) Clinical Data Warehouse Adverse Event Reporting System

Documentum EDM Document Life Cycle Management eCTD E Submission Sharepoint

Document Management, eCTD for IND/NDA GCP/CFR 21 Part 11 Validation Data Standards (HL7/CDISC/SPL/ICSR/RPS eClinical (trial data management, trial supplier managemnet, statistics ePRO, Clinical Trial Registry and Results Database

Effectiveness of Medicine Long-term Safety Life Cycle Management Patient Registry Observational Outcome Research Pharmacoeconomics Global Registery

Data Governance, Data Integration, Information Management and Knowledge Sharing

8

PHARMA R&D BUSINESS PROCESS: TWO TYPES OF R&D. TRANSLATIONAL IS THE

INDUSTRY DIRECTION BUT PRESENTS THE GREATEST SET OF CHALLENGES.

• Silos between disciplines and within and between institutions

• A number of different disciplines: Chemical,

Biological, Clinical etc.

• In many ways has hit a wall in terms of efficiency and capacity for innovation

• Rich history of many applications and data-

providers

• Integrates traditional discovery processes with clinical practices

• Breaks down boundaries between silos and organizations

• Closes the cycle between research and the clinic, and between different research disciplines

• Requires collaborative infrastructures and data access

• Process is circular (closed loop)

Basic Research

Discovery and

Development

Clinical

Trials

Manufacture and

Distribute Primary

Care

Extended Acute

Health

Management

Payment

Translational R&D Traditional R&D

9

VIRTUAL R&D, COLLABORATION AMONG ACADEMIC MEDICINE, PHARMACEUTICAL

COMPANIES AND REGULATORY BODIES MANDATE EFFECTIVE INFORMATION

MANAGEMENT AND KNOWLEDGE MANAGEMENT

Basic

Science

Statistics

Informatician

Clinical Care &

Research

Patient recruitment • Receive current standard

therapy

• On clinical trial of new therapy

Prospective biomarker

screening in new

patients

Statisticians develop tools

to analyze and validate

biomarkers

In vivo and in silico prospective

and retrospective biomarker

use in discovery

Hypothesis generation

Biopharma Companies

conduct and develop

putative new treatment

Biospecimen collection, clinical

diagnosis and treatment to

assess biological activity and

hypothesis

Clinical Care

Basic Science

Informatics

Drug Discovery

Development

Disease

Management

Payment

Clinical

Research

THE NEED FOR DEVELOPING A 360 VIEW OF BIOPHARMA PRECLINICAL AND

CLINICAL DEVELOPMENT ACTIVITIES – INFORMATION MANAGEMENT HUB AND

PHARMA R&D INTELLIGENCE SYSTEM

•Animal Tox Studies

•Data to support phase 1 trials

•Dosing stability studies

•Tox analytical method development and validation

•INC support

•Patient recruitment

•Site selection and monitoring

•Investigator relationship management

•Test sample logistics

•EDC

•Phase I safety study

•POC Study

•Clinical data reduction

•DRA

•IND Review

•Biomarker ID & Validation

•Clinical Compendium Dx kits development

•Phase I simulation, modeling and virtual patients

•Clinical protocol development

•Analytical development

•Pilot Manafacturing

•Technology Transfer

•Clinical Supplies Manufacturing,QA/QC

•CMC section of NDA

•Dosage form Stability

Clinical PK/PD

•Phase I trial review

Design &

Planning

Start-up Recruiting patients

and Investigators,

managing trial

Closeout & Report

Key Activities

benefiting from

information

management

• Designing protocols

• Creating regulatory docs.

• Planning, ordering drug

supply

• Distributing drug information

• Setting up data collection

• Selecting site

• Monitoring progress & adverse

events

• Managing drug supply

• Tracking patient enrollment

• Tracking clinical-response forms

• Entering & verifying data

• Processing clinical response

forms

• Addressing and reconciling

investigators’ queries

Trial Phases

1. Clinical Data

Management

Database of investigators and

their preferences to support

design of electronic forms

Standard interface to integrate

third party pay systems quickly

and inexpensively

Automated data checks to minimize

queries

Information Management

4. Clinical-Trials

Management

Modular design, construction

of consent and case report

forms

System to convert study

designs to electronic forms and

databases with minimal rework

and manual effort

Electronic invoicing

Automated drug supply work flow

Study planning and budgeting

Patient Management

Report Builder

3. Document

Management

Single repository of data with version control, work flow management.

2. Safety Data

Management

Real-time monitoring and analysis of study data to spot adverse reactions.

5. Project &

resource

Management

Ability to track and analyze cost, quality and speed Standard data models to work

with third-party contractors

INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL TRIAL PROCESS

INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL

DATA REPOSITORY (CDR) BUSINESS CASES

• New R&D model requires extracting and use data and

metadata from all the transactional systems and aggregate

them into a comprehensive clinical trial management

environment.

• Definition of a Clinical Data Repository: a centralized metadata

repository fed by all the key systems (EDC, CTMS, IVRS, CDMS,

Labs, Genomics, Resource and Planning) to allow for retrieving,

combining, analyzing and reporting on operational data for

multiple purposes.

INFORMATION MANAGEMENT OPPORTUNITY – COMPREHENSIVE

PHARMACOVIGILANCE SYSTEM BUSINESS CASES FOR DRUG SAFETY

AND POST MARKET SURVEILLANCE SYSTEM

• Traditionally, Pharmacovigilance seen as drug adverse-event case processing, relatedness assessment and regulatory compliance reporting.

• Public safety concern and new R&D and commercial models require a comprehensive benefit-risk analysis on drug development and drug life cycle management.

• New bars on drug safety and post market surveillance require a comprehensive pharmacovigilance system

• Definition of a comprehensive pharmacovigilance system: possess ability to process safety data, to detect safety signals, to assess preclinical and clinical potential safety concerns/risks. The goal of the system is to enhance safety monitoring, to communicate identified safety risks, to provide strategies for implementing risk minimization

BUSINESS INTELLIGENCE: TRADITIONAL

CORPORATE BI VS. PHARMA R&D BI

R&D BI Traditional Corporate

BI

Corp DW

• Structured texts

• Clear business rules

• Data residing in various dbs

ERP

CRM

MRP

SFA

R&D DW

Number

Text

Images

Gene

Compound Structure

Structured DB

Predictive Models

• Heterogeneous data

• Out-of-dated data

• Unstructured and structured

• Data resides internally and externally

Reports

Visualization

Interactive Reports

DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION

MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (1)

DATA INTEGRATION MATURITY

No

Integration in

Discovery,

standalone

LIMS, paper-

based CRF

Minimally Integrated,

Pilot Programs on EDC,

loosely harmanization

between CTDM and

AERS, separate

research databases

within therapeutic area

Federated Querying,

within research

discipline (Genomics,

Medicinal Chemistry)

and clinical (EDC,

CTDM, CTMS and

AERS) as stop-gap

solutions

Full Discovery

(Targets to

leads)

Preclinical (Tox,

DMPK) and

Clinical

Lifecycle

Integration

Full Integration

including

Research,

Preclinical and

clinical data

Integration

with

Commercial

(EBM,

Personalized

Medicine)

P2 P6

P5

P4 P3

P8

P7

P9

P10

P12

P11

DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF

INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (2)

DATA MINING AND ANALYTICS MATURITY

No data

mining and

analytics

capabilities.

Heavy use of

Excel

spreadsheets

Some data mining and

analytics capabilities,

SAS in biostatistics,

various loosely-

coupled informatics

tools implemented in

discovery, preclinical

mostly associated

siloed applications

and some signal

detection in safety

Data repository

environment for

informatics and

analytics developed

in discovery,

preclinical and

clinical. Analytic

results still

application and

database specific.

Siebel analytics

reports CRM reach of

frequency but not

marketing analytics

Information

Analytics

environment

no longer

specific to

single

application

and databases.

Some

dashboards

capabilities

Enterprise

Data Analytics

and

Information

Workbench

with

customized

dashboards

P2 P6

P5

P4 P3

P8

P7

P9

P10

P12

P11



INFORMATION ARCHITECTURE AND DELIVERY

CAPABILITIES

No information

architecture

consideration.

Ad-hoc queries

as needed for

single

application.

Manual review

of multiple

queries to

answer a single

question

Information

architecture built

mostly based on

vendor supplied

standards. Siloed IT

groups develop

SQL/database queries

strategies based on

employee skillsets.

Information delivery

via window/Mac/web

interfaces as needed

Siloed IT initiated

integration based on

SOA and portal.

Example: Discovery

gene/compound

databases integrated

with project

portfolios. Clinical

data warehouses

being built to

integrate EDC, CDMS

based on industry

standards

Enterprise MDM

initiatives about

targets,

compounds,

products,

customers,

suppliers and

patients along

the R&D+M

value chains.

SOA and web

services

adopted

Enterprise

MDM delivered

on-demand.

Well thought-

out SOA in

place and

enterprise web

services

groups in

place.

Information

delivery based

customized

portal and

access control

P2 P6

P5

P4 P3

P8

P7

P9

P10

P12

P11



LEVERAGING EXTERNAL

INFORMATION/COLLABORATION CAPABILITIES

No external

collaboration

and no need to

access external

information –

non existent

Access external

information via ftp,

internet and VPN

eROOM, sharepoints,

stand alone EDC,

large scale R&D and

clinical project

management based

on MS projects and

visios

Third party project

management tools

chosen. R&D and

Clinical implemented

document life cycle

strategies.

Documentum and

other content

management tools

chosen for

information

archiving and

regulatory

submissions

Fully leverage

industry

standards of

information and

apply semantic

webs and

ontology

standards.

External

information

integrated on-

demand and

based on

business needs

P2 P6

P5

P4 P3

P8

P7

P9

P10

P12

P11

PHARMA SALES, MARKETING AND

MANAGED CARE

• Business Challenges

• Evolving Business Models


HARNESSING INFORMATION MANAGEMENT

FOR PHARMACEUTICAL S&M

Information Management Opportunities

• Global IM approach provides better insights and added value

from core and emerging markets

• Global shared services allow robust integration of data sources

and systems to drive efficiencies, support quality decisions and

reduce costs

• Consistent, and consolidated data improves performance

measurement such as launch success rate, product

penetration rate across regions, globally and therapeutics

areas.

• Integration of pharma, hospitals and payers data help realize

the vision of EBM

• Integration of pharma, hospital, retails, PBM provide a more

intelligent, integrated market view across national market, and

alternative distribution channels

• Comprehensive dashboards drive optimal brand management

at the global level and increase brand growth through

performance measurement

• Integration of marketing analytics allow for better measurement

of effectiveness of DTC and online marketing

• Consolidated reporting strategies reduce market research

reporting costs,

Business Challenges

• Emerging Market

• Cost Containment

• Generic Market

• Specialty Products and

Biologics

• Managed Care

• New Distribution Channels

• Evidence based medicine

(EBM)

• DTC/Online Marketing

• eDetailing

• Precision Medicine

Managed Markets

Formulary Strategy

Sales Territory Alignment/

Management

Marketing Segmentation

& Targeting

Go

ve

rna

nc

e

Infrastructure

Data Warehousing/Information Management

Master Data Management

(Customer, Product, Organization)

REFERENCE ARCHITECTURE FRAMEWORK FOR A TYPICAL

PHARMACEUTICAL SALES, MARKETING AND MANAGED CARE

ORGANIZATION

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UNDERSTAND ANALYTICAL NEEDS: WHAT BUSINESS QUESTIONS

SALES AND MARKETING EXECUTIVES ASK LEAD TO DESIGN STRATEGY

OF INFORMATION MANAGEMENT

22

© Copyright 2007 HP

S&M Analytical Areas: Groupings of KBQs into Analytical Areas to facilitate needs

analysis.

Analytical KBQ Areas

• Market Performance

– The analysis of Client’s position in the marketplace

over time against competitors.

• Customer Segmentation

– The analysis of Customer behavior using groupings with similar

characteristics that allow Client to tailor their communication

and investments in an optimal fashion.

• Sales Tracking and Analysis

– The analysis of Script behavior across Customers and

associated Sales Force activity and effectiveness.

• Lifecycle Management

– The analysis and between the drugs in various stages and

Customer behaviors.

• Event Analysis

– The analysis of the impact and effectiveness of Customer

Event activities and other communication touchpoints.

• Patient Outcome Analysis

– The analysis of patient adherence to product

prescription/regimen and the rate of outcome achieved. May

include comparisons to results expected from clinical trial

systems.

These Analytical Areas allow us to analyze

current challenges and issues associated with

robustly answering KBQ’s that are similar in

ways such as:

• Data Capture.

Data not captured in Client systems

consistently. May point to process, application

or organization issues or data does not exist.

• Data IntegrationData exists across multiple systems, e.g.

KOLs kept on multiple lists.

• Information AccessNo direct access or Analytical tools available.

• Data QualityIssues include sufficiency, completeness,

accuracy.

• What is segment script writing behavior by region, by brand, by geography?

• How do customers in various segments compare on script volume?

• Which customers within a therapeutic class have the most per product

market share and what is it?

• What is the brand adaptability by graduation date or specific school?

• How do we track segmentation of non-physician prescribers?

• What products have reached their saturation threshold with specific

customers both now and forecasted?

• How many patients are in a doctors practice and what are the demographics

over time?

• Which doctors influence the purchasing of which institutional entities for

example, nursing homes?

• What is the retention time of a prescriber towards Client over time by

product?

• How much does a customer cost to pursue and is there a significant

variance in this by segment or region?

• How do we utilize segments at the household level for a practice entity?

• Is there a relationship between patient adherence and customer script

growth? If so, what is it?

• Who are the Key Opinion Leaders (KOL) by therapeutic area, by

geography?

• Which customers are most profitable by segment, by region?

• How can the best segment based opportunities be identified?

• What is the lifetime value of a doctor?

• What is the brand switching behavior of products by customer, by segment,

by therapeutic class, by time, by geography?

• How can Client distinguish between brand switching and new scripting habits

when there are steep changes in market share (e.g. significant decrease

within a short time period)?

• How does segmented customer level market share compare to competitors

within a product class?

Entities

• Addresses

• Affiliations

• Brand Hierarchy

• Compound

• Customers

(Individual/ Org)

• Identifier

• Financial

• Healthcare Provider

(HCP)

• Market Hierarchy

• Patient

• People

(Employees, etc.)

• Physical Assets

• Product

• Product Hierarchy

• Promotion

Product

Other Vendor IMS

• Market

• Subclass

• Franchise

• Brand

• Strength

• Market Group

• Market

• Sub Market

• Sub Market a

• Sub Market b

• Brand

• Product

• Strength

• Packaging

THE TYPICAL MASTER DATA ENVIRONMENT IN THE INDUSTRY IS DIVERSE. A

THOUGHTFUL APPROACH IS NEEDED TO RATIONALIZE MDM WHILE STILL

MAINTAINING BUY-IN FROM USERS

Client

Siebel SFA

salesforce.com

IMS WKH

External

Data

Customer Master

Storage is in Visage.

No history.

Customer List

Manual

Resolution for

Rejects

Client In-house Developed System. IBM

WebSphere QualityStage for

standardization and miscellaneous tools for

matching.

Future Needs:

• Internal Client Customer Lists, Medical

Affairs, KOLs, etc.

• Track affiliations e.g. nurses with

patients.

• Data vendor Customer level.

Customer Mastering

Customer List

Believed to drop

Customers for non-

core products, even

competitor data.

Product Mastering

SAP ECC Siebel

Salesforce.com

IMS WKH

External

Data

???

Future Needs: Data vendor with competitor

products. Their data may be sourced at a more

granular level than today (today, at an

aggregated and used at therapeutic class level).

Production Hierarchy:

Compact and slowly

changing.

No true Product mastering

process is in place

especially for competitor

and switching analysis

more granular than

therapeutic class.

Geography/Territory Mastering

Custom

Alignment

Siebel

Salesforce.com

Siebel may both filter

and transform CA

data.

• Alignments have

different hierarchies e.g.

for Specialty, General

Practitioner and Primary

• Geography: State, FSA,

postal groups etc.

Client In-house Developed System

Employee Mastering

PeopleSoft Siebel

Custom

Alignment

• Lacks all

Reps in field.

• Manages

hierarchies for

HR purposes.

Contains

contractors not

in PeopleSoft.

Illustrative Pharma Mastering Environment

PHARMACEUTICAL SALES, MARKETING AND DISTRIBUTION

MODEL IS EVOLVING

It was It is or will be

•Large sales forces

•Captive sales forces

•Product focused

•Broad detailing; often manual and push oriented

•Primary product with multiple other products

•Single or few channels for product or disease

information

•Single relationship based

•One size fits all

•Simple channels: Offices; educational seminars,

hospitals

•Physician or influence individual focus

•Single company sales

•Direct to Consumer (DTC) nascent

•Substantial sales force overhead time

•Smaller sales force per geography

•Fewer drugs in the bag, more targeted patient groups --

all are equally important

•Contract sales forces that ramp up and down quickly

•Specialist and clinical scientists focused, fewer

products to discuss, but deeper disease stage

discussions

•Multiple channels/contact points; tiered contacts e.g.

MSLs, nurses, reps; Web, TV, wikis, physician and

consumer portals, social media

•Disease management focused

•Insight-led, Information based touchpoints e.g. knowing

outcomes and safety issues

• Develop customer and prospect segmentation

strategies that enable effective differentiation and

targeting of offerings.

•Empowered managed care account manager for payer

account management

•eDetailing, pull oriented, physician pull

•Collaborative sales; joint sales with multiple companies

•Sophisticated DTC to all demographics

•Reduced Rep overhead time

TO MEET EVOLVING BUSINESS NEEDS, INFORMATION MANAGEMENT

MATURITY LEVEL WILL NEED TO BE INCREASED AS WELL

•Start global

mastering with

local customer

masters

limited IM maturity Intermediate IM maturity Future IM Maturity

•Syndicated, global data

feeds hubs

•Longitudinal patient

centric predictive models

to predict outcomes

Customer Centric View

Patient Centric View

360 Degree of All

Customers and Patients

•Electronic medical

records with integrated

genomic profiles. •Automatic, integrated

safety reporting with

single point of data entry

(e.g. harmonized

vocabularies for clinical

data)

•Physician spend data

integration with tight

linkages to ERP systems.

•Off-the-label activities

completely automated

and tracked

•Real-time analytics aids

faster and frequent

territory coverage

remaps

• Integrated data mining

assists in pharma-

covigilance and exploit in

outcome based research

•Highly centralized and

standardized

•Start data quality

programs

•Start MDM

shared service

organizations

•Simplified Information

architecture and

framework; standardized

and consolidated.

• Integrated SFA and

CRM

•Start to develop

integrated

marketing channels

•Establish new

compensation plans

•Support for flexible sales

force structures as #

realignments increases.

•Start to develop

eDetailing POCs

• Implement integrated

eDetailing

•Real-time S&M

effectiveness and ROI

analytics

•Gather new

channel information

to measure

effectiveness.

•Limited real-time S&M

data.

•Larger amounts of diverse

data integration; data

fusion; unstructured and

structured.

•Global master data

management systems as a

value-add shared service.

•Region based IM

•Start integration

maps with

standard

definitions

PHARMACEUTICAL COMPANY IS CHANGING FASTER THAN BEFORE. MOST COMPANIES

LACK THE INFORMATION MANAGEMENT (IM) INFRASTRUCTURE TO SUPPORT CHANGE

AND ACCOMMODATE LOCAL COUNTRY NEEDS

Illustrative Informatics Value Stack

Customer and Patient

Analytics & Reporting

Data

Data Integration, Quality

and Governance

IT Infrastructure • Regionally centralized; master data hubs

• Generally infrastructure not outsourced but

changing

• Shared services oriented

• Some applications may be offered in SAAS

model for some countries

• S&M Transaction data is configured regionally

• Master Data is implemented regionally and

locally, some opportunities for global master

data

• Shared services model where possible (Master

Data, analytics data, external data), some

regional and some global

• Governance is local and regional, very few global

• Quality rules are being standardized at local

level, but local variations will remain

• Good master data and reference maps speed-up

data integrations

• DI and DQ are implemented as shared services;

success varies

• Global platform and tools, local/regional

implementation

• Master data and DI offers new analytic

possibilities

• Specialty data mining more outsourced.

• Standard tools typically used such as BO, Cognos. Other

tools not proven globally, e.g. Siebel Analytics, embedded

reporting apps.

• Different lens created regionally, globally and different

functional areas e.g. R&D and S&M.

• Programming labor outsourced.

• Standard tools, may be some regional

• Volume demands different approach to infrastructure for

global scalability

• Different lens created for different groups is key

functionality; forced standardization has not worked well

overall

• Local data services are offered due to local regulations

• Efforts underway to standardize data for global analytics,

primarily around disease

• Maintenance is outsourced, not the content/quality

• Some definitions are being standardized

• Uniform hardware and software, few regional/local

variations

• Apps and db maintenance often out-sourced.

• Standard tools and platforms

BRIDGING THE GAP BETWEEN

PHARMACEUTICAL MANUFACTURERS AND

HEALTHCARE PROVIDERS, PAYERS AND

GOVERNMENT

• Healthcare Economics and Outcome Research (HEOR)

• Quality Index of Medical Care and Evidence based Medicine mandated

by Center for Medicare and Medicaid and the Healthcare Reform Act

• Pay for Performance Reimbursement Model by Healthcare Payers

• Superior clinical benefits and longitudinal impact demanded by

Healthcare Providers

PHARMACEUTICAL MANUFACTURING

AND DRUG SUPPLY CHAIN

• Manufacturing Process and Challenges

• Drug Supply Chain Process and Challenges

• Federal and State Pedigree Legislation


PHARMACEUTICAL MANUFACTURING (GMP)

29

Pharmaceutical

Development

Technology

Transfer

Commercial

Manufacturing

Product

Discontinuation

Investigational Products

cGMP

Quality Assurance (QA) and Quality Control (QA) System

Corrective Action/Preventive Action (CAPA) System

Knowledge Management and Information Management

PHARMACEUTICAL SUPPLY CHAIN PROCESS

30

Chargeback

Rebate Payment

Returns / Recalls Credit

Order Payment

Order Payment

Financial Forward Reverse

Returns / Recalls Credit

Shipments

Shipments

Shipments

Product Forward Reverse

Pharmaceutical Co

Returns / Recalls

Returns

Returns / Recalls

Wholesaler

Pharmacy

PBM

Return Resale

PHARMACEUTICAL SUPPLY CHAIN CHALLENGES

31

Counterfeiting /

Product Diversion

Regulatory

Compliance

Supply Chain

Management

and Visibility

Improving

Quality of Care

The level of pharmaceutical counterfeiting is

approximately 5-10% of world trade. This represents a

direct revenue loss of $24-$49B for the industry

Several states (California, Florida,etc) have state

legislation on drug pedigree. Federal Government (FDA)

is considering adoption of track & trace technologies.

Customers are beginning to apply the technologies for

product recalls

Pharma experiences $2B in returns annually. The

estimated typical percentage of a facility’s total monthly

Rx volume returned by customers is 4% for distributors

and 2% for manufacturers.

Increasing FDA concern on contaminated or ineffective

products. 60% of counterfeits did not contain any active

ingredients; 19% contained a wrong dosage and 16%

contained inappropriate agents.

INFORMATION MANAGEMENT OPPORTUNITIES

32

Manufacturer Wholesaler Retail

Production DC DC Chain DC Retail Store

Pedigree

Drug ID Info

Manufacturer

Pedigree

Drug ID Info

Manufacturer

Pedigree

Manufacturer

Drug ID Info

Wholesaler

Re-packaging

Pedigree

Drug ID Info

MFR Pedigree

Pedigree

Manufacturer

Drug ID Info

Re-packaging

Hospitals/Doctor’s Office

Pedigree

Drug ID Info

Re-packaging

Pedigree

Drug Id Info

MFRPedigree

Wholesaler Wholesaler

MFR Pedigree

MFR Pedigree

Pedigree

Drug ID Info

Repacker

MFR Pedigree

MFR Pedigree

TRACKING DRUG SUPPLY CHAIN DATA FLOW

PHARMACEUTICAL IT MANAGEMENT

• CIO Challenges

• Metrics that demonstrates aligns IT values to business priorities

• IT Innovation Metrics that tied to biopharmceutical companies

• Information Management Opportunities to help IT organization run like a business

CIOS FACE A BALANCING ACT: CONTAIN IT COSTS, DELIVER HIGHER

QUALITY SERVICES AND APPLICATIONS AND LEAD INNOVATION IN A

FAST-PACED BUSINESS ENVIRONMENT.

WW Spending (US$B)

Your Average IT Operational spending

growing at 3x other systems costs

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

$200 New server spending (USM$) 3% CAGR

’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08

Cost of mgmt. & admin. 10% CAGR

WW Spending (US$B)

Your Average IT Operational spending

growing at 3x other systems costs

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

$200 New server spending (USM$) 3% CAGR

’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08

Cost of mgmt. & admin. 10% CAGRCost of mgmt. & admin. 10% CAGR

Trading analytics

Document transfer

Call center inquiries

Airline operations

Track financial position

Supply chain updates

Phone activation

Trade settlement

Build-to-order PC

Refresh data warehouse

107 106 105 104 1,000 100 10 1 Seconds

3 days 45 seconds

30 minutes 5 seconds


8 hours 10 seconds

1 day 5 minutes

1 day 15 minutes

3 days 3 minutes

1 month 1 hour

6 weeks 24 hours

5 days 1 day

Mail/ express/ fax/ e-mail30 seconds3 days

Trading analytics

Document transfer

Call center inquiries

Airline operations

Track financial position

Supply chain updates

Phone activation

Trade settlement

Build-to-order PC

Refresh data warehouse

107 106 105 104 1,000 100 10 1 Seconds

3 days 45 seconds



8 hours 10 seconds

1 day 5 minutes

1 day 15 minutes

3 days 3 minutes

1 month 1 hour

6 weeks 24 hours

5 days 1 day

Mail/ express/ fax/ e-mail30 seconds3 days

Speed

Cost Quality

Run IT ‘AS’ a business Run IT ‘FOR’ the business

Average IT operational spending growing at 3x other systems costs.

ILLUSTRATIVE METRICS: AN INTEGRATED SET

IS NEEDED TO UNDERSTAND IT VALUE.

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

– Support new sales

channels

– Improve time to market

– Better customer business

processes

– Increase use of

collaborative tools

– Contribute to business

case development

– Technology refresh

– Reduce app. dev. time

– Better business

understanding

– Faster recruitment

– Provide integrated

performance criteria

– % of sales through new

channel

– % of project delivery on time

and on budget

– No. of IT-driven improvement

opportunities identified

– No. of identified opportunities

realized

– % of projects using coll. tools

– % of projects with IT

contribution

– Time spent vs. planned

– % of desktops >3 years old

– % of new projects using RAD

methods

– No. of bus. edu. forums

– Time to fill job requests

– % of staff with business

initiative measures in review

criteria

Objective Metrics Actual Target

9%

N/A

2

1

60%

70%

N/A

25%

20%

N/A

90 days

10%

15%

90%

10 per

year

8 per

year

90%

100%

+/-5%

<5%

80%

10 per

year

45 days

75%

– Web/kiosk initiative

– New products

program

– Value management

program


program

– New products

program



– Infrastructure 2007

– Development 2006

– Bus. education forum

– Employee dev. plan

– Personal dev. plan

Initiatives

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers


channels



processes

– Increase use of

collaborative tools


case development



– Better business

understanding





channel


and on budget




realized



contribution




methods





criteria


9%

N/A

2

1

60%

70%

N/A

25%

20%

N/A

90 days

10%

15%

90%

10 per

year

8 per

year

90%

100%

+/-5%

<5%

80%

10 per

year

45 days

75%

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers


channels



processes

– Increase use of

collaborative tools


case development



– Better business

understanding





channel


and on budget




realized



contribution




methods





criteria


9%

N/A

2

1

60%

70%

N/A

25%

20%

N/A

90 days

10%

15%

90%

10 per

year

8 per

year

90%

100%

+/-5%

<5%

80%

10 per

year

45 days

75%

– Web/kiosk initiative

– New products

program


program


program

– New products

program




– Development 2006

– Bus. education forum

– Employee dev. plan

– Personal dev. plan

InitiativesInitiatives

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

– Reduce IT Cost

– Maximize ESP

Performance

– Sustain appropriate cust.

sat. levels through 2004

– Provide a secure IT

environment

– Technology consolidation

– Standardization of

development

– Thin-client simplification

– Keep and attract staff

– Improve hiring and

promotions

– % of reduction in CAPEX

– Cost of service comparison

– Weighted % (by importance/

cost) of contractual

achievement

– IT opinion survey/satisfaction

rating

– % of compliance to policy

– No. of monthly incidents

– No. of departmental servers

eliminated

– % of two-screen desks

– Change in IT development

costs as proportion of total

– % of conversion of possible

desktops

– % of staff with important

training needs not addressed

– % of open requests unfilled in

>10 weeks

– No. of key positions with no

successor ready in < 6 months


1.5%

N/A

75%

3.25

80%

2 per

month

143

9%

N/A

45%

N/A

15%

1

– 2006 “to the bone”

– Vendor management

program

– IT customer sat.

survey

– Enterprise security

program






– Personal

development program

– employee

development plan

– employee

development plan

5%

+/- 8%

85%

3.5

100%

<4 per

month

400

0%

-5%

95%

<15%

20%

2

Initiatives

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

– Reduce IT Cost

– Maximize ESP

Performance




environment



development




promotions





achievement


rating




eliminated





desktops




>10 weeks




1.5%

N/A

75%

3.25

80%

2 per

month

143

9%

N/A

45%

N/A

15%

1

IT

Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

– Reduce IT Cost

– Maximize ESP

Performance




environment



development




promotions





achievement


rating




eliminated





desktops




>10 weeks




1.5%

N/A

75%

3.25

80%

2 per

month

143

9%

N/A

45%

N/A

15%

1


– Vendor management

program

– IT customer sat.

survey

– Enterprise security

program






– Personal

development program

– employee

development plan

– employee

development plan

5%

+/- 8%

85%

3.5

100%

<4 per

month

400

0%

-5%

95%

<15%

20%

2

IT Value Proposition Starts with:

IT Value Proposition Oriented towards Innovation and Growth IT Value Proposition Targeted to Cost Containment Goals

IT Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

–Optimize the return on IT

investment

–Contribute value to

business processes

–Optimize use of

enterprise services

–Streamline business unit

services

–Technology migration

–Establish value focus

–Faster application dev.

– Improve moves, adds and

changes (MAC)

management

–Leverage ESP

–Attract and retain staff

with appropriate skills for

services offered

– % of revenue spent on IT

– % of IT budget spent on new

investments


rating

– Infrastructure alignment index

– Post-acceptance satisfaction

score

– Application alignment index

– % of facilities at company

standards

– % of projects coming through

value process

– On-time delivery

– % of SLA requests to install met

– No. of versions installed at same

time

– No. of software releases and

dist. methods per platform

– % of noncore positions

outsourced

– Attrition rate improvement


1.2%

15%

N/A

0.85

2.5

0.50

75%

50%

30%

70%

N/A

N/A

25%

-2% per

year

Initiatives

2%

50%

75%

2.0

4.0

2.0

95%

100%

90%

100%

<3

max. 2

95%

10% per

year

– Value mgmt. program

– Program mgmt.


– Program mgmt.


– Program mgmt.








– Employee development

program

IT Mission/Value

IT Customers

Internal IT

Processes

Enabling

Technologies

IT

Organizational

Enablers

–Optimize the return on IT

investment

–Contribute value to

business processes

–Optimize use of

enterprise services

–Streamline business unit

services

–Technology migration

–Establish value focus

–Faster application dev.

– Improve moves, adds and

changes (MAC)

management

–Leverage ESP

–Attract and retain staff

with appropriate skills for

services offered

– % of revenue spent on IT

– % of IT budget spent on new

investments


rating

– Infrastructure alignment index

– Post-acceptance satisfaction

score

– Application alignment index

– % of facilities at company

standards

– % of projects coming through

value process

– On-time delivery

– % of SLA requests to install met

– No. of versions installed at same

time

– No. of software releases and

dist. methods per platform

– % of noncore positions

outsourced

– Attrition rate improvement


1.2%

15%

N/A

0.85

2.5

0.50

75%

50%

30%

70%

N/A

N/A

25%

-2% per

year

Initiatives

2%

50%

75%

2.0

4.0

2.0

95%

100%

90%

100%

<3

max. 2

95%

10% per

year


– Program mgmt.


– Program mgmt.


– Program mgmt.








– Employee development

program

• Aligning IT objectives to

relevant business units goals

• Developing metrics to track

progress

• Launching key IT initiatives to

support those goals

INNOVATION METRICS ARE PARTICULARLY IMPORTANT TO PHARMACEUTICAL CIO

AS MORE COMPANIES ARE FACING PATENT CLIFF AND REVENUE SHRINKAGE

Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available, expressed as a percentage

Effort normally gets split between Maintenance,

Enhancement, operations and new projects. Infrastructure,

M&E spending is largely non-discretionary and mostly not

value creating in the same way as new projects are. The

significance of this measure the larger the proportion I&M&E

spending is of the IT budget, the less proportionately there is for new projects.

LagPercentage of effort on new projects

Innovation

Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date) allocated to strategic projects (as defined), divided by the total new development budget for the same period

A measure that attempts to quantify how much innovation is

taking place. Since this is a notoriously difficult factor to

manage, surrogate measures are usual: number of patents,

number of invitations to speak at conferences, number of publications in peer reviewed journals.

LeadLevel of activity in innovation work.

Innovation

Year to date measure. The total number of "learning events" heldA (qualitative) measure of knowledge sharing - usually a

survey or surrogate measure such as documents referenced

or designs reused - scaled by the number of learning events:

meetings, teleconferences and so on, to gauge how effective these learning events are

LeadKnowledge Sharing & Learning Events Held

Innovation

Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a

score of high and very high to the question regarding 'This is a place that encourages innovation" , divided by the total numberof full-time-employees completing the survey

A measure that attempts to quantify the almost

unquantifable. The only meaningful way of applying this

measure is to seek the opinion of a competent authority and

use this opinion to show the degree to which the environment encourages innovation

LeadExtent to which an

environment is in place

which encourages innovation

Innovation

Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused

assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the asset type

An aggregate measure of the age of hardware assets,

usually divided into categories (mainframe, servers,

desktops). This measure is useful if demonstrating the

impending need to replace assets or for planning asset refresh cycles

LeadAverage age of hardwareInnovation


Measure of the degree to which IT budget can be directed into new - and strategic or high pay off - projects

Lead% of new development

budget for strategic projects

Innovation

Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches (as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent

An architectural target measure charting the adoption rate of

Rapid Application Development, an interactive prototyping approach to application development

Lead% new projects using RAD Methods

Innovation

Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and the date recorded

Measure of the level of innovation exercised by the IT groupLead# Of patents and other awards

Innovation

Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined), divided by the total number of new development projects, expressed as a percent

A measure indicating the uptake of new technologies (such

as RFID and so on, depending on the enterprise's

requirement) Usually expressed as a proportion of projects

underway, there is a definitional issue that must be resolved:

to what extent does a new technology have to be part of the

project before it can be counted? 1% of budget? 10% of budget...

LagNumber of New Technology Applications

Innovation

Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available, expressed as a percentage

Effort normally gets split between Maintenance,

Enhancement, operations and new projects. Infrastructure,

M&E spending is largely non-discretionary and mostly not

value creating in the same way as new projects are. The

significance of this measure the larger the proportion I&M&E

spending is of the IT budget, the less proportionately there is for new projects.

LagPercentage of effort on new projects

Innovation


A measure that attempts to quantify how much innovation is

taking place. Since this is a notoriously difficult factor to

manage, surrogate measures are usual: number of patents,

number of invitations to speak at conferences, number of publications in peer reviewed journals.

LeadLevel of activity in innovation work.

Innovation

Year to date measure. The total number of "learning events" heldA (qualitative) measure of knowledge sharing - usually a

survey or surrogate measure such as documents referenced

or designs reused - scaled by the number of learning events:

meetings, teleconferences and so on, to gauge how effective these learning events are

LeadKnowledge Sharing & Learning Events Held

Innovation

Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a

score of high and very high to the question regarding 'This is a place that encourages innovation" , divided by the total numberof full-time-employees completing the survey

A measure that attempts to quantify the almost

unquantifable. The only meaningful way of applying this

measure is to seek the opinion of a competent authority and

use this opinion to show the degree to which the environment encourages innovation

LeadExtent to which an

environment is in place

which encourages innovation

Innovation

Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused

assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the asset type

An aggregate measure of the age of hardware assets,

usually divided into categories (mainframe, servers,

desktops). This measure is useful if demonstrating the

impending need to replace assets or for planning asset refresh cycles

LeadAverage age of hardwareInnovation


Measure of the degree to which IT budget can be directed into new - and strategic or high pay off - projects

Lead% of new development

budget for strategic projects

Innovation

Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches (as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent

An architectural target measure charting the adoption rate of

Rapid Application Development, an interactive prototyping approach to application development

Lead% new projects using RAD Methods

Innovation

Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and the date recorded

Measure of the level of innovation exercised by the IT groupLead# Of patents and other awards

Innovation

Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined), divided by the total number of new development projects, expressed as a percent

A measure indicating the uptake of new technologies (such

as RFID and so on, depending on the enterprise's

requirement) Usually expressed as a proportion of projects

underway, there is a definitional issue that must be resolved:

to what extent does a new technology have to be part of the

project before it can be counted? 1% of budget? 10% of budget...

LagNumber of New Technology Applications

Innovation

IT INFORMATION MANAGEMENT OPPORTUNITIES: FROM

STRATEGIC IT METRICS TO CIO SCORECARD

CIO Scorecard

IT Performance Indicators

Business Impact

Financial

INFORMATION MANAGEMENT OPPORTUNITY USE CASE: LEVERAGE IT

METRICS TO HELP YOU DEVELOP A PROVEN IT VALUATION MODEL

Identify Relevant Metrics to be Tracked and Communicated

Gartner BusinessValue Model

MarketResponsiveness

SupplierEffectiveness

ProductDevelopmentEffectiveness

OperationalEfficiency

Financeand Regulatory

Responsiveness

CustomerResponsiveness

SalesEffectiveness

InformationTechnology

Responsiveness

Sales OpportunityIndex

ForecastAccuracy

ClientRetention Index

Sales CycleIndex

Sales PriceIndex

Sales CloseIndex

On-TimeDelivery

ServicePerformance

Order FillRate

AgreementEffectiveness

TransformationRatio

MaterialQuality

SystemsPerformance

New ProjectsIndex

IT Total CostIndex

IT SupportPerformance

PartnershipRatio

Service LevelEffectiveness

Human Resources

Responsiveness

Demand Management

Supply Management

Support Services


SalesEffectiveness


Responsiveness

Identify Relevant Metrics to be Tracked and Communicated

Gartner BusinessValue Model






Responsiveness


SalesEffectiveness


Responsiveness

Sales OpportunityIndex

ForecastAccuracy

ClientRetention Index

Sales CycleIndex

Sales PriceIndex

Sales CloseIndex

On-TimeDelivery

ServicePerformance

Order FillRate

AgreementEffectiveness

TransformationRatio

MaterialQuality

SystemsPerformance

New ProjectsIndex

IT Total CostIndex

IT SupportPerformance

PartnershipRatio

Service LevelEffectiveness

Human Resources

Responsiveness

Demand Management

Supply Management

Support Services


SalesEffectiveness


Responsiveness

1 2

3 4

The ITThe ITView View CSFsCSFs

The BusinessThe BusinessView View KOIsKOIs Increase

customer loyalty

Cross-selling

Billing accuracy

Faster product/serviceintroduction

Market retention

Revenue percustomer

Reduce rework

Market share

Make it easier to do businesswith the corporation

Knowledge mgmt.

Legacy sys. maint.

Reducecycle time

Customers accessingthe Web site

Cust. files

Billing-error rate

Auto. test process

No. of staff members trained on Java

DBMSstandardization

Consolidatebilling systems

Select/implement new tools

The BusinessThe BusinessView View CSFsCSFs

The ITThe ITView View KOIsKOIs

The ITThe ITView View KPIsKPIs

CSF = Critical success factor

KOI = Key outcome indicator

KPI = Key performance indicator




How the business must succeed Outcomes

of business processes How

IT must succeed Outcomes

of IT processes Measures

of IT performance

The ITThe ITView View CSFsCSFs

The BusinessThe BusinessView View KOIsKOIs Increase

customer loyalty

Cross-selling

Billing accuracy

Faster product/serviceintroduction

Market retention

Revenue percustomer

Reduce rework

Market share

Make it easier to do businesswith the corporation

Knowledge mgmt.

Legacy sys. maint.

Reducecycle time

Customers accessingthe Web site

Cust. files

Billing-error rate

Auto. test process

No. of staff members trained on Java

DBMSstandardization

Consolidatebilling systems

Select/implement new tools

The BusinessThe BusinessView View CSFsCSFs

The ITThe ITView View KOIsKOIs

The ITThe ITView View KPIsKPIs







How the business must succeed Outcomes

of business processes How

IT must succeed Outcomes

of IT processes Measures

of IT performance

Challenge: Reduce dependence on agents and lower cost of sales

Initiative: Web-based selling



Gartner Business Value Model

Business CaseBenefits: $3.2 m

Costs: 2.3 m

Net: $0.9 m

ROI: 39%

Payback: 11 Months


Costs: 2.3 m

Net: $0.9 m

ROI: 39%

Payback: 11 Months





Responsiveness

Human Resources

Responsiveness

DemandDemandManagementManagement

SupplySupplyManagementManagement

SupportSupportServicesServices



SalesEffectiveness


Responsiveness





Gartner Business Value Model


Costs: 2.3 m

Net: $0.9 m

ROI: 39%

Payback: 11 Months


Costs: 2.3 m

Net: $0.9 m

ROI: 39%

Payback: 11 Months





Responsiveness

Human Resources

Responsiveness

DemandDemandManagementManagement

SupplySupplyManagementManagement

SupportSupportServicesServices



SalesEffectiveness


Responsiveness

Target

Market Responsiveness

Channel Profitability Index 68% 76%

Sales Effectiveness

70% 73% 75%

IT Responsiveness

BaselineExternal

Benchmark

66% 72%

Sales Opportunity Index 41% 55%

Sales Close Index

Client Retention Index

43% 46% 50%40% NA

25% 35%26% 28% 31%25% NA

55% 65%57% 60% 63%53% 63%

Systems Performance

IT Support Performance

98.5% 99%98.7% 98.9% 98.6%98.2% 99%

90% 95%91% 93% 93%90% 94%

Time

Q 4Q 3Q 2Q 1

How is the Web initiative going?

Partnership Ratio

Service-Level Effectiveness

28% 50%33% 35% 38%29% 45%

79% 85%82% 85% 84%80% 84%

New Projects Index

IT Total Costs Index

47% 60%50% 54% 59%48% 57%

3.2% 3.1%3.3% 3.1% 3.2%3.2% 3%

Target

Market Responsiveness

Channel Profitability Index 68% 76%

Sales Effectiveness

70% 73% 75%

IT Responsiveness

BaselineExternal

Benchmark

66% 72%

Sales Opportunity Index 41% 55%

Sales Close Index

Client Retention Index

43% 46% 50%40% NA

25% 35%26% 28% 31%25% NA

55% 65%57% 60% 63%53% 63%

Systems Performance

IT Support Performance

98.5% 99%98.7% 98.9% 98.6%98.2% 99%

90% 95%91% 93% 93%90% 94%

Time

Q 4Q 3Q 2Q 1

How is the Web initiative going?

Partnership Ratio

Service-Level Effectiveness

28% 50%33% 35% 38%29% 45%

79% 85%82% 85% 84%80% 84%

New Projects Index

IT Total Costs Index

47% 60%50% 54% 59%48% 57%

3.2% 3.1%3.3% 3.1% 3.2%3.2% 3%

Link business to IT performance management… …using business metrics to attract business interests…

…Provide post-implementation tracking

using metrics agreed with Business. …linking IT initiatives to business metrics and

ROI…

INFORMATION MANAGEMENT FRAMEWORK

39

ESTABLISHING INFORMATION MANAGEMENT ARCHITECTURAL

FRAMEWORK AND BUILDING THE CAPABILITIES WILL BE

CRUCIAL TO SUPPORT THE CHANGING BUSINESS LANDSCAPE

• Master and Reference

Data

• Business Intelligence

Data

• Transaction Data

• External Data

• Semi-Structured Data

• Unstructured Data

• Data Access

• Data Delivery

• Data Integration

• Process Integration

• Transformations

• Business Rules

• Meta Data Repository

• Enterprise Data Models

• Service Registry

• Directories

• BI Definitions and

configurations

• Integration Definitions

• Access Definitions

• Delivery Definitions

• Transformation Definitions

• Process Definitions

• Business Rules Repository

IM Framework components… …defined by…

• Business Goals & Principles

• IT Goals and Principles

• IM Organization

• Enterprise Governance

• Information Governance

• Service Governance

• Process Governance

• Application Governance

• Infrastructure Governance

• Change Management

• Information Lifecycle Management

• Compliance & Risk Management

• Enterprise Architectural Standards

…and driven by:

Typical IM Strategy Process map

Information Access

Information Architecture &

Integration

Information Quality (MDM)

• IM Governance

• Technical

Architecture

• Service

Definition

MASTER DATA MANAGEMENT SOLUTION FRAMEWORK: THINK LOCALLY,

STANDARDIZE REGIONALLY, ANALYZE GLOBALLY. DO NOT “OVER MASTER.”

EDM Governance & Stewardship –

Acq

uis

ition

& A

uth

orin

g S

erv

ices

Dis

tribu

tion

Serv

ices

Metadata Services

Master Data

Management

Services

Data Quality Services

Administration

Services

Maintenance

Services

Master Data Consumers

Acquisition & Authoring

• Real-time/Near • Batch • Change Capture

Distribution

• Self-service (pull) interface • Publishing (push) interface • Messaging-oriented interface

Data Quality

• Validation • Audit, balance & control • Quality Tracking

Metadata

• Metadata shopping • Impact analysis • Operations Monitoring • Quality Investigations

Administration and Maintenance

• Change management • Security management • Operational support • Process monitoring • Performance management

Stewardship Process

• Distribution Request • New/changed Master Data Request • Quality Improvement Initiative • Operations & Quality Monitoring

Master Data Management

• Historical Data Management • Storage services • Schema services • Mapping/alignment Services • Hierarchy Management

Suppliers

• Authoritative Sources • End-user Authoring

Master Data Suppliers

Workflow Services

Workflow Services

• Review and Correction • Approval and Publishing • Exception escalation

information management in pharmaceutical industry

Health & Medicine